25 results · 23ms · Sources: EU EUDAMED, US FDA

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LYMA Laser

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PRISM XPVT SYSTEM (210823)

FDA 510(k)
FDA Class 2 ·Radiology

SOLUTION SYSTEM

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086994·SOLUTION SYSTEM THINSHAFT REAMER 11mm DIA

PRISMAFLEX

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPAZZ

FDA 510(k)
FDA Class 1 ·Physical Medicine

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

PRISMAFLEX

FDA Adverse Event
Death ·GAMBRO LUNDIA AB·Product code KDI·April 11, 2014

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·November 2, 2012

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·February 15, 2012

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·December 23, 2013

UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 12, 2011

CONE TIP URETERAL CATHETER

FDA Adverse Event
Malfunction ·COOK UROLOGICAL, INC.·Product code FAD·July 2, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

PRISMAFLEX

FDA Adverse Event
Death ·GAMBRO LUNDIA AB·Product code KDI·January 10, 2014

PRISMAFLEX

FDA Adverse Event
Death ·GAMBRO LUNDIA AB·Product code KDI·January 3, 2014

PRISMAFLEX

FDA Adverse Event
GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·August 13, 2012